波斯尼亚和黑塞哥维那、克罗地亚、塞尔维亚及黑山的药物不良反应报告与药物警戒系统的发展：一项回顾性药物流行病学研究
Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study.
作者信息
Glamočlija Una, Tubić Biljana, Kondža Martin, Zolak Aleksandar, Grubiša Nataša
机构信息
Una Glamočlija, School of Medicine, University of Mostar, Bijeli brijeg bb, 88 000 Mostar, Bosnia and Herzegovina,
出版信息
Croat Med J. 2018 Jun 30;59(3):124-131. doi: 10.3325/cmj.2018.59.124.
AIM
To compare individual case safety reports (ICSR) rates and characteristics between Croatia, Serbia, Montenegro, and Bosnia and Herzegovina (B&H).
METHODS
This retrospective pharmacoepidemiological study used the data from ICSR received by the Agency for Medicines and Medical Devices in B&H in 2011-2016. The number, characteristics, and sources of reports, suspected drugs, and patient characteristics were analyzed. The results were compared with the publicly available data from Croatia, Serbia, and Montenegro.
RESULTS
The number of reported adverse drug reactions per one million of inhabitants was lowest in B&H and highest in Croatia. There were significant differences in reporter characteristics, sources of reports, and the percentage of missing data in ICSR, while the Anatomical Therapeutic Chemical product classes, patient's sex, and adverse drug reaction System Organ Classes were similar.
CONCLUSION
Despite the historical and geographical vicinity of B&H and its neighboring countries, there were significant differences in indicators of pharmacovigilance development.
目的
比较克罗地亚、塞尔维亚、黑山以及波斯尼亚和黑塞哥维那（波黑）的个例安全报告（ICSR）发生率及特征。
方法
这项回顾性药物流行病学研究使用了波黑药品和医疗器械局在2011 - 2016年收到的ICSR数据。对报告的数量、特征、来源、可疑药物及患者特征进行了分析。结果与克罗地亚、塞尔维亚和黑山公开可得的数据进行了比较。
结果
每百万居民报告的药品不良反应数量在波黑最低，在克罗地亚最高。报告者特征、报告来源以及ICSR中缺失数据的百分比存在显著差异，而解剖治疗学化学产品类别、患者性别以及药品不良反应系统器官类别相似。
结论
尽管波黑与其邻国在历史和地理上相近，但药物警戒发展指标存在显著差异。
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